Li L, Chen D, Wang C, Yuan N, Wang Y, He L, Yang Y, Chen L, Liu G, Li X, Ran X, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 2015 Jul 1;volume 23(4):495-505.
1. Wound Repair Regen. 2015 Jul-Aug;23(4):495-505. doi: 10.1111/wrr.12294. Epub 2015
Jul 14.
Autologous platelet-rich gel for treatment of diabetic chronic refractory
cutaneous ulcers: A prospective, randomized clinical trial.
Li L(1), Chen D(1), Wang C(1), Yuan N(1), Wang Y(1), He L(1), Yang Y(1), Chen
L(1), Liu G(2), Li X(1), Ran X(1).
Author information:
(1)Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West
China Hospital, Sichuan University, Chengdu, China.
(2)Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan
University, Chengdu, China.
The purpose of the study is to examine the safety and effectiveness of topical
autologous platelet-rich gel (APG) application on facilitating the healing of
diabetic chronic refractory cutaneous ulcers. The study was designed as a
prospective, randomized controlled trial between January 1, 2007 and December 31,
2011. Eligible inpatients at the Diabetic Foot Care Center of West China
Hospital, Sichuan University (China) were randomly prescribed with a 12-week
standard treatment of ulcers (the control group) or standard treatment plus
topical application APG (the APG group). The wound healing grades (primary
endpoint), time to complete healing, and healing velocity within 12 weeks were
monitored as short-term effectiveness measurements, while side effects were
documented safety endpoints. The rates of survival and recurrence within the
follow up were recorded as long-term effectiveness endpoints. Analysis on total
diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers
(DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was
statistically more effective than standard treatment (p < 0.05 in both total DUs
and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%)
in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58
(69.0%) and 37/55 (67.3%) in the control group from intent to treat population.
The Kaplan-Meier time-to-healing were significantly different between the two
groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were
identified after topical APG application. The long-term survival and recurrence
rates were comparative between groups (p > 0.05). This study shows that topical
APG application plus standard treatment is safe and quite effective on diabetic
chronic refractory cutaneous ulcers, compared with standard treatment.
© 2015 by the Wound Healing Society.
DOI: 10.1111/wrr.12294
PMID: 25847503 [Indexed for MEDLINE]